Status:
COMPLETED
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo...
Eligibility Criteria
Inclusion
- Patient has given written informed consent before any trial-related activity is performed.
- Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Patients who are lymph node positive or have other metastatic disease
- Use of urethral catheter
- Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
- Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
- Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00833248
Start Date
April 1 2009
End Date
September 1 2011
Last Update
October 4 2012
Active Locations (66)
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1
Alabama Research Center
Birmingham, Alabama, United States, 35209
2
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
3
Alaska Urological Association
Anchorage, Alaska, United States, 99508
4
Arizona Urologic Specialists
Tuscon, Arizona, United States, 85712